Freelance Senior CRA (Oncology) - Remote

iO Associates - UK / EU; Essen; Remote; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A leading biotechnology research company is seeking a Senior Freelance CRA with oncology experience in Essen, Germany. The role involves managing clinical trial sites, ensuring compliance with regulations, and performing on-site monitoring visits. Candidates should have a scientific background, fluency in German and English, and at least 2 years of CRA experience. This position offers flexibility and travel compensation.

Qualifikationen

• Minimum 2 years of on-site monitoring experience as a CRA.
• Fluent in German and English, both verbal and written.
• Strong understanding of clinical trial laws and guidelines.

Aufgaben

• Manage on-site stakeholder relationships throughout trial phases.
• Perform clinical study site management and monitoring.
• Conduct and document data from site visits.

Kenntnisse

Stakeholder Management

Clinical Research

Effective Communication

Data Analysis

Knowledge of ICH-GCP

Ausbildung

BA/BS in a scientific field

Tools

CTMS

eTMF

MS Office

Jobbeschreibung

iO Associates have partnered with a Global Biotechnology Research company, who're currently seeking a Senior Freelance CRA with immediate availability and senior Oncology indication experience.

This is a sponsor-dedicated role, and we're interested in speaking to CRAs with significant freelancing experience and strong references.

Role Responsibilities :

1. Manage on-site stakeholder relationships throughout trial phases
2. Perform clinical study site management and monitoring in compliance with ICH-GCP, Sponsor SOPs, site monitoring plans, local laws, and regulations
3. Handle site selection, site readiness procedures, coordination, and collaboration
4. Develop a detailed understanding of the study protocol and procedures
5. Conduct accurate, unbiased oversight activities for site data generation, ensuring subject rights and protection
6. Review regulatory documents for study start-up, maintenance, and close-out
7. Communicate with investigators and site staff regarding protocol and conduct issues
8. Conduct and document data from site visits such as initiation, monitoring, validation, and close-outs

Additional Responsibilities :

1. Escalate site performance and compliance issues via the CRA Escalation Pathway, collaborating with CRM, PLM, and RCPM
2. Manage information and documents in CTMS, eTMF, and other systems
3. Support or lead audit and inspection activities

Candidate Requirements :

• BA/BS in a scientific field with relevant bio-sector experience
• Minimum 2 years of on-site monitoring experience as a CRA (CRO/Bio/Pharma)
• Fluent in German and English (verbal and written)
• Effective communication of technical information
• Strong understanding of clinical research, GCP/ICH, clinical trial laws, and guidelines, including global and country-specific regulations
• Knowledge of Good Documentation Practices
• Proven skills in site management, performance, and patient recruitment
• Strong IT skills, including clinical applications and MS Office
• Ability to analyze data and metrics appropriately

Willing to perform 5-6 on-site monitoring visits per month in Germany. Travel time will be paid according to your hourly rate.

Please apply today or contact Adam Akhtar at iO Associates - EU for further information.

Desired Skills and Experience

ICH-GCP, SOPs, Compliance, Stakeholder Management, CIMS, eTMF, CRA, Oncology, Freelance

Position: Freelance Senior CRA (Oncology) - Remote, Essen, DE